NCT00260637

Brief Summary

Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Last Updated

October 26, 2006

Status Verified

November 1, 2005

First QC Date

November 29, 2005

Last Update Submit

October 25, 2006

Conditions

Prostatitis

Keywords

Prostatitis

Outcome Measures

Primary Outcomes (1)

  • Six point drop in NIH-CPSI total Score

Secondary Outcomes (5)

  • Individual domains of the NIH-CPSI

  • Patient reported Global Response Assessment

  • International Prostate Symptom Score

  • International Index of Erectile Function

  • Brief Pain Inventory- Short Form

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of discomfort or pain in the pelvic region for at least a three (3) months period within the last six (6) months.
  • Moderate overall score on the NIH-CPSI (overall score more than 15 out of a potential of 0-43 points)
  • Diagnosed as having CPPS Category III
  • Participant is willing to undergo 10 weeks of acupuncture treatment

You may not qualify if:

  • History of prostate, bladder or urethral cancer.
  • Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
  • Undergone pelvic radiation or systemic chemotherapy, intravesical chemotherapy or intravesical BCG.
  • Treated for unilateral orchialgia without pelvic symptoms.
  • Active urethral stricture.
  • Undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
  • Neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
  • Liver disease.
  • Diagnosed as acute or chronic bacterial prostatitis.
  • History of urinary tract infection positive uropathogen for the past year.
  • Taking medications which could affect the lower urinary tract function
  • History of type 1 or 2 diabetes.
  • Treated/currently undergoing treatment with acupuncture for any other illness including prostatitis for the past 6 months.
  • Refusal to be needled or any form of bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Metro Hospital

Sungai Petani, Kedah, 08000, Malaysia

Location

Hospital Lam Wah Ee

Batu Lanchang, Pulau Pinang, 11600, Malaysia

Location

Hospital Pantai Mutiara

Bayan Lepas, Pulau Pinang, 11800, Malaysia

Location

Island Hospital

George Town, Pulau Pinang, 10400, Malaysia

Location

Related Publications (2)

  • Lee SW, Liong ML, Yuen KH, Krieger JN. Acupuncture and immune function in chronic prostatitis/chronic pelvic pain syndrome: a randomized, controlled study. Complement Ther Med. 2014 Dec;22(6):965-9. doi: 10.1016/j.ctim.2014.10.010. Epub 2014 Oct 23.

    PMID: 25453515DERIVED

  • Lee SW, Liong ML, Yuen KH, Leong WS, Khan NK, Krieger JN. Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment. Acupunct Med. 2011 Mar;29(1):40-6. doi: 10.1136/aim.2010.003137. Epub 2011 Jan 18.

    PMID: 21245238DERIVED

MeSH Terms

Conditions

Prostatitis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Men L Liong, MD

    Consultant Urologist

    PRINCIPAL INVESTIGATOR

  • John N Krieger, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kah H Yuen, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

February 1, 2004

Study Completion

August 1, 2005

Last Updated

October 26, 2006

Record last verified: 2005-11

Locations

MY(4)